Cleared Traditional

K223421 - MedCAD AccuPlan Orthopedics System

K223421 is an FDA 510(k) clearance for MedCAD AccuPlan Orthopedics System, manufactured by Medcad. The device is a Class 2 Orthopedic device with product code PBF cleared through the Traditional 510(k) pathway after a 314-day FDA review.

K223421 · Medcad · Orthopedic device
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Sep 2023
Decision
314d
Days
Class 2
Risk

K223421 is an FDA 510(k) clearance for the MedCAD AccuPlan Orthopedics System. Classified as Orthopaedic Surgical Planning And Instrument Guides (product code PBF), Class II - Special Controls.

Submitted by Medcad (Dallas, US). The FDA issued a Cleared decision on September 20, 2023 after a review of 314 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3030 - the FDA orthopedic device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

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FDA 510(k) Submission Details - K223421

510(k) Number K223421 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 10, 2022
Decision Date September 20, 2023
Days to Decision 314 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
192d slower than avg
Panel avg: 122d · This submission: 314d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

PBF Device Classification - Class 2, Special Controls

Product Code PBF Orthopaedic Surgical Planning And Instrument Guides
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3030
Definition As A Surgical Instrument To Assist In Pre-operative Planning And/or Guiding The Marking Of Bone And/or Guide Surgical Instruments For Orthopedic Surgical Procedures.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Orthopedic devices follow this clearance model.

Regulatory Peers - PBF Orthopaedic Surgical Planning And Instrument Guides

All 26
Devices cleared under the same product code (PBF) and FDA review panel - the closest regulatory comparables to K223421.
CORIOGRAPH Knee Pre-Op Plan
K240113 · Smith & Nephew, Inc. · Mar 2024
Fine Osteotomy™
K240066 · Bodycad Laboratories, Inc. · Feb 2024
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K221615 · Newclip Technics · Oct 2023
Fine Osteotomy™
K231314 · Bodycad Laboratories, Inc. · Jun 2023
MyPAO Guides
K220706 · Medacta International S.A. · May 2023
EmbedMed
K221943 · 3D Lifeprints UK , Ltd. · Feb 2023